Medsider: Learn from Medtech and Healthtech Founders and CEOs - How to Get a Medical Device Startup Off the Ground: Interview with Asha Parekh, CEO of FrontLine Medical Technologies

Episode Date: June 21, 2021

In this episode of Medsider Radio, we’re talking with Dr. Asha Parekh, a biomedical engineer and the co-founder & CEO of FrontLine Medical Technologies, a Canadian medical device startup. FrontLine has developed a novel REBOA device that helps trauma patients survive in emergency situations. If you're not familiar, REBOA stands for Resuscitative Endovascular Balloon Occlusion of the Aorta.In this discussion with Asha, we learn about her medtech journey from early-stage device prototypes to raising venture capital to navigate the global regulatory landscape. But first, here’s a bit more on Asha’s background:Asha has a Ph.D. in biomedical engineering from Western University in Ontario. In 2015, she partnered with Dr. Adam Power, a practicing vascular surgeon, to co-found FrontLine, which makes the COBRA-OS device for trauma patients. Before we jump into the conversation, I wanted to mention a few things:If you’re into learning from proven medtech and healthtech leaders, and want to know when new content and interviews go live, head over to Medsider.com and sign up for our free newsletter. You’ll get access to gated articles, and lots of other interesting healthcare content. Second, if you want even more inside info from proven experts, think about a Medsider premium membership. We talk to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a medtech startup for an exit.In addition to the entire back catalog of Medsider interviews over the past decade, Premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world’s most successful medtech founders and executives. Since making the premium memberships available, I’ve been pleasantly surprised at how many people have signed up. If you’re interested, go to medsider.com/subscribe to learn more.Lastly, here's the link to the full interview with Asha if you'd rather read it instead.

In terms of actually raising, I will say for equity funding, don't settle too quickly. I mean, we were very fortunate in our fundraising, but a lot of the traditional places and people that are in the space, I will say they'll likely try to convince you that you have to settle and perhaps lower your expectations to get funded. I mean, the truth is every case is different. We both know that. And, you know, I'll just say I think it's worth weighing. your options carefully because, you know, you have an idea or eventually you'll have an idea when you're fundraising, when you go out there, what you're okay with, the terms are okay with,

evaluation. And, you know, sometimes when someone's dangling money in front of you and you need money, you know, it can be really tempting, even if it's not on the terms you want. And it can seem perhaps like the easier option to take it. But it is on their terms. And I guess my, my, my piece of advice is to strive for your terms and that's really what we did. You know, we had our terms and we said, we're going to go for it. I mean, again, we were maybe lucky, but we were successful in doing it. And, you know, it may not always be possible. You know, you may not always get the terms that you want, but the harder you try, I think the closer you'll get to that. Welcome to Medsider Radio, where you can learn from proven medtech and healthcare thought leaders through uncut and unedited interviews.

Now, here's your host, Scott Nelson. Hey, it's Scott. In this episode of Medsider, we're talking with Dr. Asha Parak, a biomedical engineer, and a co-founder and CEO of Frontline Medical Technology is a Canadian medical device startup. Frontline has developed a novel Ribo device that helps trauma patients survive in emergency situations. If you're not familiar with that acronym, neither was I before this interview, but it stands for resuscitative endovascular balloon occlusion of the aorta. In this discussion with Asha, we learned more about her Medtech journey from early stage device prototypes to raising venture capital to navigating the global regulatory landscape. Before we dive in, here's a bit more on her background.

Asha has a PhD in biomedical engineering from Western University in Ontario. In 2015, she partnered with Dr. Adam Power, a practicing vascular. surgeon to co-found Frontline, which makes the Cobra OS device for trauma patients. Okay, so before we jump into the discussion, I want to mention a few things. First, since you're listening to Medsider, you're probably aware of how expensive it is to run clinical trials. Anyone who spent time in the MedTech space knows that you typically need to commit hundreds of thousands of dollars, oftentimes millions, towards clinical research. But it doesn't have to be that way. And here's why. Prove Pilot is a new kind of hybrid clinical trial platform that enables you to

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forward slash proofpilot to learn more. Okay, second, if you're into learning from proven medtech leaders and want to know when the new content and interviews go live, head over to medsider.com and sign up for our free newsletter. You'll get access to gated articles and lots of other interesting healthcare content. If you want even more inside info from med tech experts, think about a medsider premium membership. We talked to experienced healthcare leaders about the nuts and bolts of running a business and bringing products to market. This is your place for valuable knowledge on specific topics like seed funding, prototyping, insurance reimbursement, and positioning a MedTech startup for an exit.

In addition to the entire back catalog of MedSiter interviews over the past decade, premium members get exclusive Ask Me Anything interviews and masterclasses with some of the world's most successful MedTech founders and executives. Since making the premium memberships available, I've been pleasantly surprised at how many people have signed up. So if you're interested, go to medsider.com to learn more. All right, without further ado, let's get to the interview. All right, Asha, welcome to Medsider Radio.

Appreciate you coming on. Thank you. Thanks for having me, Scott. All right. Well, I recorded kind of your more formal bio, sort of at the outset of this episode of this episode. But I always like to start off kind of with the way you describe your personal background leading up to your time at Frontline. So let's start there. Sure.

I will start by saying I was born and raised in Canada's lovely capital city of Ottawa. That's probably going back way longer than either of us have time for. But just a tidbit of information there. I moved to London to go to Western University. And I guess by the time I finished my PhD, I was too loud and proud of a purple Mustang to leave. So I've been in London, Ontario ever since. finished my PhD in biomedical engineering in 2015. And then I went on to do a couple of postdoctoral

fellowships. And it was actually during one of those fellowships, the medical innovation fellowship where I met Dr. Adam Power, who is a practicing vascular surgeon, but I like to think more importantly, my business partner, and he's a co-founder and CMOA Frontline. So we met during that fellowship, but it was actually the following year that we started developing the Cobra OS device through Frontline. And we had just been, you know, working on other projects. And when this idea developed, it took off pretty quickly, actually. So there was some funding available for healthcare startups that we applied for and got approved for. And, you know, we both right from the start felt very strongly about the impact that this device could make. And that's what really led us

to discussions and ultimately the decision to give this a real go. So that, you know, we founded Frontline at that time. I jumped into this world of entrepreneurship to get it off the ground. And we haven't looked back since. Yeah, that's great. I love the high level overview. And there's certainly some things that I want to unpack before we go too far into kind of what the early, early formative years of frontline looked like. But you mentioned that you've got a PhD in biomedical engineering from Western University. Is your undergrad degrees in the same field? Yeah. So at the time, actually, Western did not offer a biomedical engineering undergrad. It does now, happy to say that we have developed a biomedical engineering undergrad program here now, but I did biochemical at that time.

Okay, got it, got it. So let's talk a little bit more about those experiences like in your postdoc, because I, there's a fair amount of, um, whether MDs and also, you know, folks in graduate school, whether they're in PhD programs or master's programs that are, that are entrepreneurial, like, oriented or minded and come across, you know, various ideas. So when you were in your postdoc, did you, did you envision kind of like, you know, kind of going into one, the met tech space or even like, you know, even more interesting, like starting your own. device company? Yeah, you know, being completely transparent. This was not planned at all. You know, going from my, I did have some industry exposure, even from my PhD. I worked with a company there. But going into, so the first postdoctoral fellowship that I did was this medical innovation fellowship. So just to, you know, give a little bit of a background there, it's not a traditional postdoctoral fellowship. So, you know, an academic postdoc, is quite different. So the Medical Innovation Fellowship is actually all structured around medical device commercialization.

You basically, there's a series of sections in the program that you go through, but it's basically you spend that, if I were to sum it up in a sentence, you basically spend your engineering, trying to engineer new medical devices for unmet clinical needs. So that is what gave me the first exposure really to, you know, get a taste of what entrepreneurship could look like. Again, even at that point, there was no plan to start a business. You know, it all kind of unfolded naturally. And, you know, as I mentioned, it was actually the following year that we actually even decided to do this and came up with this idea. So for me personally, it wasn't like an intentional plan. But I will say I'm very be happy to hear a lot of students that I speak to at speaking engagements or, you know,

and conferences and other platforms now that a lot more people are considering this as, you know, an alternative to the traditional academic or industrial pathways and, you know, are setting an intentional plan to start their own business. Got it. Okay. And would you compare the medical innovation kind of fellowship that you did at Western? Is it somewhat similar to the Stanford Bio Design Program? Are there some heroes?

I love that you know about that. Of course you do. But it was actually, yeah, so this program is run in conjunction with the University of Minnesota. But this whole program that, like, it is all based on the Stanford program. So that is kind of where the idea stemmed from. Got it, got it. Yeah. And for those listening that are familiar with the University of Minnesota program, you might find an interview I did with Dr.

Art Erdman. Gosh, it's probably dating back seven or eight years ago now, but it was a great interview, and we learned a lot more about that type of program at the University of Minnesota. So good stuff. That's super cool to kind of, and I'm sure that, you know, as we learn a little bit more about your story, it'll be especially interesting knowing that you didn't necessarily intend, you know, to finish up this fellowship and start a med tech company. But I want to learn a little bit more about the COBRA OS device, but maybe first tell us,

like what it is and then take us back in time to like how this idea came about because I know you referenced your CMO who's a vascular surgeon. Sounds like maybe the idea sort of originated with him. But kind of tell us, let's start with what it is, you know, that kind of the pain points that your device solves for and then and then we'll learn a little bit more about the origin stories. Yeah, yeah, happy to do that. So the COBRA OS, you know, it is a medical device. It is a temporary device. I will start by saying that, you know, basically, mostly for trauma, it's used right now. And trauma in situations where there's internal bleeding.

So if you can imagine, you know, a civilian setting or a military setting, if somebody has an injury to their hand or their leg, you can apply pressure to it and try to stop the bleeding. But when it's in your torso region, it's internal bleeding, you can't really compress it and effectively stop the bleeding. So unfortunately, a lot of those patients bleed out if you're outside of a hospital before they can make it there to get into the hands of a surgeon. And so the intent with this type of device is that you put in the device to the patient and basically you, basically you block blood flow above the injury. And so you're turning off the top to the lower limbs and to the injury site. But what you do, by doing that, you're making sure that your brain and your heart continue to receive blood.

Those are the two vital organs to keep you in good standing if you are going to survive this type of injury. And so that is at a high level, you know, basically you're short circuiting that so your heart is now not pumping to your whole body, but you've made the circuit your brain and your heart. And then, again, it is a bridge. It's not definitive care. you take the patient to somewhere where they can receive definitive care and you would remove our device. Got it. Got it. So is this a completely like novel type of technology? It's not like you saw something that currently existed and just really wasn't that good and you improved upon it. Is this completely new? No, so that's exactly what we did. Actually. Yeah. Yeah. You know, coming up with that concept,

to be quite honest, we would have to do a lot more studies, many, many more studies to prove that that is safe. But, you know, it is actually lucky for us that the concept of blocking the aorta and short-circuiting the body has already been done. So that kind of the crazier concept, the larger concept of it is not what we're trying to prove here. It actually dates back, you know, several years ago, but only recently did it really start to, you know, get marketed for this application. So, you know, there, I would say, there, there are a few similar types of technologies out there. And to broadly speak about the differentiation that you asked about, a lot of it comes down to the technology. So the procedure itself requires right now,

you know, a very high level of skill to do. You know, it's not necessarily the easiest for somebody out in the field to be doing this type of procedure. And so, you know, we don't necessarily want the untrained person doing it at this time. A lot of it comes down to. Yeah, yeah. And so, and it also takes a lot of time. So, I mean, on average, even in a controlled setting, like a hospital, some of the data that's out there is, you know, an average of eight minutes.

And, you know, if you think about somebody bleeding for eight minutes, I'm sure you can appreciate that a lot of blood can be lost in that time. Sure. Yeah. And so again, to differentiate with what makes ours so great and disruptive to this market is primarily comes from the size. We call it the profile, which really just means the size. You're putting a device into a relatively small artery. and the bigger that device is, the more complicated and more time it takes.

And, you know, again, potential complications arise the larger that devices. So we've been able to, and I know, again, this is going to be maybe a little bit too much into the weeds, but starting, you know, with devices that are still used, our 12 French, which is just a, it's, It's a measurement of the diameter. So the equivalent is something like four millimeters. And, you know, right now there are devices that have come down in size to about seven French. And, you know, they were called the game changers because they were able to lower that size by so much. And we have actually come with a four French device, which is like 1.3 to 1.5 millimeters.

It's tiny, you know, and so that that's where a lot of the benefits come from because that actually also reduces the number of steps that need to be used. So it reduces the time along with some other features. But that is the, I'll be honest, a lot of people don't believe that you can have a four French device that does what our device does. So that is probably the key feature there. Got it. No, that makes sense. And you answered my next question, which was going to be like what are you, you know, there's existing devices that are currently being used, but what did you try to optimize more? And it definitely sounds like profile or size. It's kind of the biggest, the biggest differentiator there. On that note, like that probably serves as a good transition to talk a little bit more about like how this idea even came about.

And you mentioned Dr. Adam Power. So can you take us back to like, I think you mentioned you were in your postdoc fellowship maybe when, you know, when you and Dr. Power kind of, you know, sort of work it worked on this. idea, but tell us a little bit more about what that looked like in the, you know, in the back of the napkin sort of days, if you will. Yeah, definitely. Well, you know, you hit the nail on the head. You know, he, as a surgeon, you know, Adam was, he saw the problem firsthand, right? Like, the patients that could have survived, the complications that were occurring in these cases. So, he was able to identify that need. And, you know, truly being able to be able to. And, you know, being able to to draw on where those complications are coming from, you know, basically is what got the ball rolling. And then we met and we had to make things happen and we had to make things and make

bigger things happen, I should say. From there, it just, you know, naturally took its course. You know, we started working together like, yeah, like you said, during the fellowship. And from there, because things were moving pretty quickly once we got that funding and, you know, we decided to make the leap. Yeah, it has really just taken a life of its own. Got it. Got it. And so in those early days, when you're kind of, I can imagine you're maybe, you know, kind of really going from zero to one where you've got this, you know, this idea that Adam kind of, you know, brings to you. You're a biomedical, you know, engineer.

you have your PD, so you're obviously pretty familiar with how to build things, right? Before getting funding, like, I mean, did you, did you struggle with finding, you know, the resources to try to start, you know, start prototyping and, you know, to sort of like make something tangible? Tell us a little bit more about that, because I think there's a lot of, and the reason I ask is there's a lot of folks that listen, that are in the Medsider community that have great ideas, right? They're in the trenches. They see all kinds of ideas, but they don't know how to even get started, right? And you and I both know how hard it is to raise money without something tangible. So tell us a little bit more about those prototyping days. Oh, yeah. That's the

fun stuff, right? Like literally pulling at like, how can we do this? You know, there were, let's say, you know, going from party balloons to other balloon type materials that were used. used to see, you know, even for a proof of concept, I'm trying to use my, choose my words carefully here. You know, basically the concept, you have the concept and how how we went about it was to say, how can we achieve this? So we want to achieve this, this, this and this. And for all of those things, what are our options and what's the best, you know, combination of all of these things to make the best device. And so we started prototyping again with things as simple as a party balloon and just

seeing if we could, you know, achieve by concept in in models that were not relevant at all, of course, as I'm sure, you know. Yeah. So, I mean, I would say there were definitely a few more than a few iterations to kind of get things going. but it didn't take long at all. You know, as I said, things moved quickly. It didn't take long to get to a point where we knew we could make this into a working commercial device

and we needed to get the prototyping on a more sophisticated scale, at which point we enlisted help from a bigger company. Got it, got it. And tell us a little, I want to talk a little bit more about kind of your approach to regulatory as well as how you begin to think about like establishing some clinical evidence. But since we're on, we're in the kind of these, you know, this part of the conversation we're talking about some of the early days. What, what did that look like? I mean, raising money for early stage med tech, you know, concepts is extremely tough. So you mentioned you partner with the biggest, a bigger company. Did the initial capital infusion come from, from sort of the, you know, an accelerator or did it, did it come from

somewhere else? Yeah. So we, yeah, the initial funding was from a program that was partially funded by a local medical network and then FedDef, so our government of Canada. Yeah. And beyond that, yeah, I mean, you're very right. And I think we all know, like, if a startup, a pre-revenue startup doesn't have money, it is very hard to get things done. So, you know, we knew we were good for that first year.

And then we knew we had to start fundraising. And, you know, we've had a little bit, a little bit further help with grants. So, you know, a little bit more government funding. But we have privately raised the rest of our funds. And so to give a little bit more detail around that, we did, I'm sure you've heard of a safe agreement. Yeah. Yeah. So simple agreement for future equity.

So we did our first raise on a safe. And then when we did another equity round, we converted. the same. Got it. And for those for those other, you know, MedTech entrepreneurs that are in a similar boat, maybe they received a little bit of, you know, grant funds or maybe they've thrown in their own, their own capital or maybe raise a little bit from the family. What are some of the best tips that you learned, you know, raising that early, early stage money because, you know, in, in experience as well as, as well as, you know, a lot of the, a lot of the folks that I've interviewed here from MedSide Radio. I mean, those are typically the toughest rounds to raise, right? When you're just, you're just,

just trying to get out of blocks. So what were kind of your keys to success, you know, in some of those first rounds? Yeah, I mean, I will say we do always try for non-delutive. And I will say it may seem obvious, but it's surprising to me how many people don't look for non-deluded funding. The accelerators and that, you know, they can be great as well. If they do give some initial funding in those days, even a little bit can really help. But they also have other resources normally at the,

accelerators. So they help you grow in ways beyond funding as well, right, as you're getting off the ground. So I think those are definitely beneficial. In terms of actually raising, I will say for, you know, equity funding, don't settle too quickly. I mean, we were very fortunate in our fundraising, but, you know, a lot of the traditional places and people that are in the space, I will say they'll likely try to convince you that you have to settle and perhaps lower your expectations to get funded. I mean, the truth is every case is different. We both know that. And, you know, I'll just say, I think it's worth weighing your options carefully because, you know, you have an idea or eventually you'll have an idea when you're fundraising, when you go out there, what you're okay with. The terms

are okay with, evaluation. And, you know, sometimes when someone's dangling money in front of you, and you need money. It can be really tempting, even if it's not on the terms you want. And it can seem perhaps like the easier option to take it, but it is on their terms. And I guess my piece of advice is to strive for your terms. And that's really what we did.

You know, we had our terms and we said, we're going to go for it. I mean, again, we were maybe lucky, but we were successful in doing it. And, you know, it may not, always be possible. You know, you may not always get the terms that you want, but the harder you try, I think, the closer you'll get to that. Got it. I love the advice, especially, especially from your perspective, kind of as a, as a first time med tech entrepreneur. And I'm in the back of my head,

I'm thinking about, like, you know, I asked Renee Ryan the same comment. She's a pretty well-known met tech entrepreneur that's sort of sat on both sides of the table, you know, as an investor. And now she's leading Cala Health. You know, and she mentioned, something along the same lines in terms of don't settling, but she said don't settle. In essence, she was saying, like, look for the right investors, right? So you may have to settle a little bit when it comes to dilution, but also at the same time, don't settle for partners or investors that you're, more so investors that you don't want to, that you don't see as long-term partners, because that's incredibly important. So would you have to the same? Absolutely. Yeah.

Yeah, sorry to cut you off. I 1,000% agree with that. It is very, very important. And, you know, I think on every level of the business, and that is one of them, you know, who finding that good fit, you know, people may think that they're just giving you money and it doesn't matter. You know, I think it really is a key, key aspect, and especially depending on how involved they're going to be in things or, you know, if they're not involved, that's another thing as well. But that, you know, just finding that right fit for what you're looking for, absolutely very, very important. Got it. Good stuff. Good stuff. Before we transition, you kind of like your approach to in the early days to navigating the regulation and, you know, pursuing some initial clinical.

Any other tips that you'd give in terms of some of that early money besides not settling? Was there, and feel free to get into the weeds, you know, if something, if something stands out or we can, you know, we can definitely move on as well. Just before we read this equity topic. Yeah. Yeah. I think, you know, again, even the piece, about, you know, where you get the money from. It really depends on the project. But I think we covered everything. Find the right fit. You know, don't settle too quickly.

I mean, I really, like some people may have no choice. So I feel bad if, you know, someone's like, well, I should really keep added. And they, you know, but, you know, I think everyone also has that. The last thing that I wanted to say was you do have a gut check, right? You have your options, but you normally have some gut feeling about what you should be doing. And in some cases, I mean, one of the things that we have to do in this world of entrepreneurship is take risks. You know, and that is part of it as well. Hey there, it's Scott.

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